FDA.reportPublic FDA data

GLIMEPIRIDE

Product NDC
61919-720
11-digit product format
619190720
Labeler code
61919
Product ID
61919-720_5f96a278-a1bb-4538-ad47-62c83233967e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLIMEPIRIDE
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA077370
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
4 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-720IInactivated by FDA2026-07-31
excluded packagepackage61919-72061919-720-60IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077370-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORALAB2005-12-23
A077370-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORALAB2005-12-23
A077370-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORALAB2005-12-23
A077370-004GLIMEPIRIDEGLIMEPIRIDE8MGTABLET / ORALAB2005-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A077370-001AB
A077370-002AB
A077370-003AB
A077370-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077370-001GLIMEPIRIDE1MGTABLET / ORALAB2005-12-23a50c72e98297…
2026-08-01 22:54:322026-06A077370-002GLIMEPIRIDE2MGTABLET / ORALAB2005-12-23a50c72e98297…
2026-08-01 22:54:322026-06A077370-003GLIMEPIRIDE4MGTABLET / ORALAB2005-12-23a50c72e98297…
2026-08-01 22:54:322026-06A077370-004GLIMEPIRIDE8MGTABLET / ORALAB2005-12-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077370-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077370-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077370-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A077370-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDESolco Healthcare U.S., LLC86acdd9e-8637-43e4-8bf7-b3a123b871b82021-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077370
application number: ANDA077370

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b890b964-2cf0-4439-aaf3-900c9e3e9e49Product name120160602
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
d36d861f-8a90-80cc-8935-1e6be9b4c7ebProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-720-602020-01-31C16284748780-19d75b9cf-f668-f424-e053-dadaa90a57ceGLIMEPIRIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-720-60GLIMEPIRIDE60 in 1 BOTTLETABLET601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [DIRECTRX]1
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [DIRECTRX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGLIMEPIRIDE TABLET [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [DIRECTRX]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGGLIMEPIRIDE TABLET [DIRECTRX]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-720GLIMEPIRIDE TABLET [DIRECTRX]1Legacy NDC, 1 package rows20151029_1c6cc8d3-a471-4862-88b9-2fe4ce50a24f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN1c6cc8d3-a471-4862-88b9-2fe4ce50a24f1
199247glimepiride 4 MG Oral TabletSCD1c6cc8d3-a471-4862-88b9-2fe4ce50a24f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-720-606191907206060 in 1 BOTTLEHistorical